I want to register a new product which contains a new active constituent

For a new agvet chemical product that contains a new active constituent, the APVMA must approve both the active constituent and register the product.

Registering a new product which contains a new active constituent is made via:

Item 1 – New product, new active constituent—full assessment required of the active constituent and productItem 2 – New product, new active constituent—less than full assessment required of the active constituent and productItem 27 – Timeshift application (requires PAA and an agreed project plan).

Which application form do you need?

I want to register a new product containing a new active constituent for use in:

Most applications to register new veterinary chemical products containing a new active constituent are submitted as a less than full assessment (Item 2) because one or more modules can be assessed below level 1. Examples include products for use in non-food producing species and product types such as biologicals, immunobiologicals, direct fed microbials, enzymes and herbal medicines. This guidance provides further explanation where lower level assessments are applicable.

Alternatively, a timeshift application (Item 27) may apply which allows flexibility for the staged submission of data to support applications. This can streamline an application with longer assessments such as toxicology and environment by commencing before the data for efficacy and crop safety are submitted for assessment. Timeshift applications can also be used to facilitate global joint reviews (GJRs) and the use of overseas assessments.

Note: The APVMA encourages the submission of international assessments to support applications for the approval of new active constituents and registration of new products. The submission of international assessments and underlying data may reduce assessment timeframes for major applications.

Pre-application assistance

Legislation

Framework

The Agricultural and Veterinary Chemicals (Administration) Act establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale. This Act contains all of the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of chemicals.

The Agricultural and Veterinary Chemicals Code Act, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products (and their associated labels); and to issue permits and to license the manufacture of chemical products. It also contains provisions for controls to regulate the supply of chemical products; and provisions ensuring compliance with, and for the enforcement of, the code.

Statutory criteria

In addressing the criteria, the applicant may provide information, or valid scientific argument that might address a specific criterion. The following sections of the Agvet Code provide definitions for meeting the criteria:

An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard:

a) is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
b) is not, or would not be, likely to have an effect that is harmful to human beings; and
c) is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.

A chemical product meets the trade criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.

In approving a label for a container for chemical products, the APVMA must be satisfied that the label contains adequate instructions. This allows the APVMA to ensure that the risks of using the agvet chemical product are adequately mitigated through appropriate instructions.

Guidelines

6A of the Agvet Code states that the APVMA may make written guidelines for performing its functions and exercising its powers under this Code.

The APVMA has designed guidelines to help inform the APVMA and applicants as to the modules, data and information that will apply for different types of applications. The guidelines are not the law. The APVMA will have regard to it, but from time to time may depart from it when determining the modules, data and information are necessary for a particular application. The APVMA has a number of guidelines which fall under this, for example:

Applications may be withdrawn

Section 8D of the Agvet Code states that at any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant.

Timeframe and fees

Timeframe and fees

An application for approval of a new active constituent and registration of a product where less than a full assessment is required is a modular application type, therefore the fees and timeframe are variable according to the assessments necessary. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.

Depending on the registration being sought, one or more of the following Module types and levels will be relevant to Item 2 applications:

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1

Not applicable

$710

2: Chemistry

2.1 or
2.2

13 months
9 months

$9 220
$3 075

3: Toxicology

3.1 or
3.2 or
3.3

13 months
9 months
5 months

$27 920
$15 795
$4 050

4: Toxicology – Poison scheduling

4.1

13 months

$2 435

5: Residues and trade

5.1 or
5.4

13 months
4 months

$18 170
$7 465

6: Work health and safety

6.2

7 months

$3 185

7: Environment

7.1 or
7.3

13 months
4 months

$26 390
$1 720

8: Efficacy and safety

8.1 or
8.2 or
8.3

6 months
4 months
3 months

$2 370
$975
$580

9: Non-food trade (if applicable)

9

6 months

$1 175

10: Special data (if applicable)

10.1 or
10.3

13 months
7 months

Nil

11: Finalisation

11.1

3 months

$4 055

12: Limits of use

12

Not applicable

$460

Example

Scenario

Module level

Timeframe

Fee

1: Register a new antibiotic for use on a food producing species

1, 2.1, 3.1, 4.1, 5.1, 6.3, 7.3, 8.1, 10.1, 11.1, 12

16 months
23 months (extended assessment period)

$70 245

2: Register a new vaccine for use on a non-food producing species

1, 2.2, 3.3, 6.2, 7.3, 8.1, 10.3, 11.1, 12

12 months
17 months (extended assessment period)

$19 625

Depending on the proposed usage and situation, Module types 2–10 will require the provision of supporting data and/or scientific argument. Where an applicant considers that an assessment of any particular module is not necessary justification must be provided.

This application type is subject to an extended assessment period if a section 159 of Agvet Code notice is sent requesting additional information or clarification of submitted information. The extended assessment period will vary, depending on the nature of the application and the modules specified for that particular application.

Modules

The APVMA has developed a Guideline for module descriptors to provide guidance as to the modules that will apply for different types of applications. The APVMA will have regard to it, but may depart from it, when determining which modules are necessary on a case by case basis. The guideline is not the law.

Module 1: Preliminary assessment

Preliminary assessment is an initial examination of the application for administrative completeness. It is an administrative check that the form and content of the application meet the application requirements. In other words, the outward look of the application and its accompanying information appears to be in order and complete. It is not a completeness check of the technical aspects of your submission.

Applies to all modular application items.

Module 2: Chemistry

There are general guidelines for chemistry and manufacture of agricultural and veterinary products available and you should consider any of the specific guidelines which relate to your product type.

2.1: Chemistry – Level 1

a. A new product with a new active constituent including:

an active constituent manufactured by chemical synthesis;

a highly purified and well characterised active constituent derived from plants or animals;

a semi synthetic active constituent manufactured by the chemical modification of a highly purified and well characterised intermediate derived from plants or animals;

a semi synthetic active constituent manufactured by the chemical modification of an intermediate produced by conventional fermentation;

active constituent produced by conventional fermentation or using recombinant DNA technology (excluding products described in module 2.2 paragraph (a) below);

an active constituent produced by transgenic technology (excluding products described in module 2.2 paragraph (a) below);

an active constituent that is a growth regulator, antibiotic or polypeptide; or

some animal tissue extracts and some plant extracts or oils.

Module level

Module type

Timeframe

Fee

2.1

Chemistry

13 months

$9 220

2.2: Chemistry – Level 2

a. A product not included in module 2.1 including:

new biological products:

new immunobiological;

immunobiological products with a major change to seed strains (including substitution of source or the addition of antigen) such that it is considered a new product;

new direct fed microbial products;

new enzyme products; or

new herbal products.

Module level

Module type

Timeframe

Fee

2.2

Chemistry

9 months

$3 075

Module 3: Toxicology

This module assesses both toxicological data and scientific argument, together with any cited references, which characterise the risks to humans using or coming into contact with the substances in your product.

The level of assessment applied for a new active constituent is generally determined by the situation that the new product will be used in. Generally, module 3.1 applies to food related situations, module 3.2 applies to non-food related situations, and module 3.3 applies to new biological based products.

3.1: Toxicology – Level 1

a. A product containing a new active constituent for food species (other than applications referred to in module 3.2 or 3.3 below).

Module level

Module type

Timeframe

Fee

3.1

Toxicology

13 months

$27 920

3.2: Toxicology – Level 2

a. A product containing a new active constituent for a non-food species.

Module level

Module type

Timeframe

Fee

3.2

Toxicology

9 months

$15 795

3.3: Toxicology – Level 3

a. A product containing a new biological active constituent for a non-food species.

All new agricultural and veterinary substances require consideration under the Poisons Standard, before an active constituent can be approved and a product containing that substance is registered by the APVMA.

Module level

Module type

Timeframe

Fee

4.1

Toxicology—poison schedule classification

13 months

$2 435

Module 5: Residues and trade

Residues assessment includes the establishment of residues definition, maximum residue limits (MRLs), and withholding periods (WHPs), and the assessment of the trade implications including the establishment of any export intervals (EIs).

There are general guidelines for both Residues Part 5A and Overseas trade Part 5B available and you should consider any of the specific guidelines which relate to your product type or extension of use.

The APVMA may decide that a residues assessment is not required when a veterinary chemical is unlikely to enter the food chain through the proposed use pattern.

This would apply to situations such as companion animal products. Residues assessment is also not required for veterinary vaccines which do not contain novel adjuvants and/or excipients.

5.1: Residues – Level 1

a. A product containing a new active constituent to be used in a food species.

Module level

Module type

Timeframe

Fee

5.1

Residues and trade

13 months

$18 170

5.4: Residues – Level 4

c. where residues do not occur in foods or animal feeds; or where the residues are identical to or indistinguishable from natural food components; or otherwise are of no toxicological significance and an MRL is not necessary (Table 5 entry in the MRL Standard is appropriate).

Module level

Module type

Timeframe

Fee

5.4

Residues and trade—limited residue assessment

4 months

$7 465

Module 6: Work health and safety

A work health and safety (WHS) assessment is required where there is a change to human exposure. Changes to human exposure can occur when extending into new crops or situations. These exposures include changes such as application rate, method, worker rates and practices including post application activities. The change in exposure may result in a change to the entry in the First aid instructions and safety directions (FAISD) handbook, including changes to personal protective equipment (PPE) and re-entry into treated areas following application.

Generally, most veterinary chemical products will be assessed under module 6.2 for WHS. In limited circumstances e.g. a new biological strain a limited assessment (module 6.3) may be applied.

6.2: Work health and safety – Level 2

a. A product containing a new active constituent for use in food species.

Module level

Module type

Timeframe

Fee

6.2

Workplace health and safety

7 months

$3 185

Module 7: Environment

Where there is any potential risk to the environment, an appropriate environmental assessment is required. This assessment will take into account the expected volume of use; the expected exposure, behaviour and fate of the active constituent/s; and the potential harmful effects on flora and fauna; resulting from use of the product.

7.1: Environment – Level 1

a. A product containing a new active constituent (unless included in a VICH Phase 1).

The VICH website has guidance on both Phase I and Phase II assessments.

Module level

Module type

Timeframe

Fee

7.1

Environment

13 months

$26 390

7.3: Environment – Level 3

a. Applications involving a VICH Phase I environmental impact assessment. A VICH Phase I environmental impact assessment may apply to applications to register a product.

The VICH website has guidance on both Phase I and Phase II assessments.

Module level

Module type

Timeframe

Fee

7.3

Environment

4 months

$1 720

Module 8: Efficacy and safety

Efficacy assessment ensures that the product works as described on the label, when used according to label directions.

Safety assessment ensures that the product is safe to use on or in the target crop or animal, when used according to label directions.

An efficacy and safety assessment may include assessing the effect of the product on crops, non-target crops and germinaton, effects of residues, organoleptic tests or pharmacologic studies.

Module 8: Efficacy and safety

Efficacy assessment ensures that the product works as described on the label, when used according to label directions.

Safety assessment ensures that the product is safe to use on or in the target crop or animal, when used according to label directions.

An efficacy and safety assessment may include assessing the products effect on target and non-target animals, effects of residues and pharmacologic studies.

8.1: Efficacy and safety – Level 1

a. A product containing a new active constituent for use in food species or companion animals.

Module level

Module type

Timeframe

Fee

8.1

Efficacy and target animal safety

6 months

$2 370

8.2: Efficacy and safety – Level 2

a. A product containing a new active constituent for use in food or fibre species other than cattle, sheep, pigs and chickens.

Module level

Module type

Timeframe

Fee

8.2

Efficacy and target safety

4 months

$975

8.3: Efficacy and safety – Level 3

a. A product where only bioequivalence (including scientific argument) is required to demonstrate the efficacy and crop safety to a currently registered product where the product is defined as similar to an existing registered product.

Module level

Module type

Timeframe

Fee

8.3

Efficacy and target safety

3 months

$580

Module 9: Non-food trade

The non-food trade module is applied to applications involving trade risks not related to food residues.

9: Non-food trade

the presence of disease or seropositive testing to exotic or notifiable agents;

hormonal growth promotants and other endocrine substances; or

Module level

Module type

Timeframe

Fee

9

Non-food trade

6 months

$1 175

Module 10: Special data assessment

This module applies to all applications for registration of a new chemical product or variation of the particulars or conditions of a registered chemical product, which contain active constituents that are new antibiotic substances or which contain genetically modified organisms (GMOs) require a module 10 assessment.

10.1: Special data – Level 1

Assessment of an active constituent containing a genetically-modified organism (GMO).

Module level

Module type

Timeframe

Fee

10.1

Special data

13 months

$Nil

10.3: Special data – Level 3

a. A product containing GMOs.

Module level

Module type

Timeframe

Fee

10.3

Genetically modified organism

7 months

$Nil

Module 11: Finalisation

This module encompasses administrative steps relating to the finalisation of the application. This can include public consultation, entering the required information into the relevant record or register, and the completion of the technical evaluation and risk assessment report outlining the evaluation of the application.

11.1: Finalisation

b. A variation where three or more modules between 2.1 to 10.3 apply.

Module level

Module type

Timeframe

Fee

11.1

Finalisation

3 months

$4 055

Module 12: Limits on use of information

Module 12 relates to the protection, handling and use of information provided to the APVMA. In general, the APVMA must not use information given to it in connection with one application to assess or make a decision on another application, except in specific circumstances. These circumstances include, but are not limited to, where the applicant has given consent for the information to be shared or in an emergency situation; see CCI Practice Statement. This ‘limited use data’ includes information such as reports, studies and scientific arguments that may or may not include confidential commercial information. The applicant can request the module at the time an application is lodged, but the APVMA may also include it once an assessment of the application is undertaken.

Module level

Module type

Timeframe

Fee

12

Data protection

N/A

$460

Pre-application assistance

Applications where Poison scheduling is required. This will include all new active ingredients or where changes are required to an established schedule for an existing active constituent (excluding vaccines).

What you need to provide

To meet the application requirements you will need to provide:

a completed online application form

the application fee plus any amount that is due to the APVMA

supporting information to demonstrate the proposed product containing a new active constituent will be efficacious and not cause unintended harm

an information list

consent for use (if any of the information provided is subject to limits of use)

The application fee

pay the preliminary assessment fee of $710 on submission and the remaining balance once the application has been accepted.

You can choose to pay by credit card, electronic funds transfer or BPAY.

Note: To meet the application requirements you must pay any amount (including an amount in respect of a tax or penalty) that is due and payable by you to the APVMA (including under a law of another jurisdiction or the agvet law).

Supporting information

The application must contain, or be accompanied by, information relevant to whether the chemical product meets the safety and efficacy criteria. Applicants should include an explanation of why they believe supporting information is not required if they choose not provide it with the application. If the APVMA accepts the justification for non-submission of specific data the application may be recategorised as an Item 2 application and appropriate modules will apply.

GM organism/Other special data
Published data and results of Australian field trials, relevant to the criteria for approval of an active constituent or registration of a product described in s.14 of the Agvet Code, may be submitted.

Consent for use from the relevant authorising party (if applicable)

The APVMA may not consider supporting information when relevant protected information is listed for the reference product, unless one of the following exceptions apply:

The applicant is the authorising party for the data associated with the reference product.

The applicant has obtained consent for use from the relevant authorising party or parties. This consent for use must be explicit and include the relevant data numbers.

Protected data details are listed in the APVMA product search database for the reference product.

Information list

It is an application requirement that all applications for approval, registration or variation include a short description of each item of information contained in, or accompanying the application—an information list.

Any document (information) submitted with the application constitutes information for the purposes of the information list. This includes supporting information, such as consent for use letters, manufacturer's declarations, MSDS, certificates of analysis, GMP certificates and other such documentation, in addition to the scientific studies or data that may be submitted to specifically address the safety, trade and efficacy criteria.

The online application form contains fields to assist applicants in entering the information required to generate the information list.

Note: Information lists are published, including details of the holders of the information. Applicants should take care not to inadvertently divulge confidential commercial information (CCI) when creating the list.

Electronic label (e-Label)

The APVMA must have regard to certain matters or details in order to satisfy itself that a label meets the labelling criteria and approve the label (sections 5D and 14 of the Agvet Code). Applicants must use the e-label template to submit the label details that the APVMA must take into account.

Assessment

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this application.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1

Not applicable

$710

2: Chemistry

A comprehensive assessment in parallel is required of the new active constituent and the product. The assessment will establish the quality and minimum composition standard of the active constituent, and the quality and shelf life of the product.

2.1

13 months

$9 220

3: Toxicology

A comprehensive toxicology assessment is needed to determine the toxicity profiles of the active constituent and the product, and impurities that may be of toxicological interest. These profiles will be used to determine suitable safety directions and first aid instructions. For the use of the antibiotic in a food-producing species, this assessment will establish an Acceptable Daily Intake, and possibly an Acute Reference Dose.

3.1

13 months

$27 920

4: Toxicology – Poison scheduling

Poison schedule classification of the new antibiotic will be confirmed.

4.1

13 months

$2 435

5: Residues and trade

New MRLs are to be established for residues of the new antibiotic in edible cattle commodities. Withholding periods (WHPs) are to be determined for the proposed use pattern of the antibiotic. Cattle meat is a major export commodity. The risk to trade will be assessed and a suitable export slaughter interval will be established.

5.1

13 months

$18 170

6: Work health and safety

It is likely that the new antibiotic will be administered mainly by a veterinarian or by the veterinary clinic staff.

6.2

7 months

$3 185

7: Environment

It is likely that the assessment of the risk to the environmental may stop at VICH Phase 1.

7.3

4 months

$1 720

8: Efficacy and safety

A full assessment is needed to verify that the efficacy trials support the label claims and the safety trials support the antibiotic can be used safely in cattle.

8.1

6 months

$2 370

9: Non-food trade

Not required as the product is intended for use on food producing animals.

10: Special data

A comprehensive assessment of antimicrobial resistance is required to determine the risk to human health and whether that risk could be mitigated.

10.1

13 months

$Nil

11: Finalisation

11.1

3 months

$4 055

12: Limits of use

12

Not applicable

$460

TOTAL

16 months

$70 245

Scenario 2: Register a new vaccine for use on a non-food producing species

Objective

Register a new live virus GMO based vaccine for dogs, which contains a new active constituent.

Assessment

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this application.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1

Not applicable

$710

2: Chemistry

A reduced chemistry assessment in parallel is required of the new antigen and the product. The assessment will establish the quality of the antigen, and the quality and shelf life of the product.

2.2

9 months

$3 075

3: Toxicology

A reduced toxicology assessment is needed to determine whether the genetically modified antigen poses any toxicological or pathogenic risks to human health. The use of a novel adjuvant in the vaccine may attract a higher level of assessment.

3.3

5 months

$4 050

4: Toxicology – Poison scheduling

No assessment necessary as all veterinary live virus vaccines are classified in Schedule 4 (with the exception of scabby mouth vaccine, pigeon pox vaccine and poultry vaccines).

5: Residues and trade

No assessment necessary as companion animals are not food-producing species.

6: Work health and safety

A reduced WHS assessment is required to assess exposure arising from the zoonotic potential of the genetically modified virus and its infectivity.

6.2

7 months

$3 185

7: Environment

If the environmental exposure potential of the vaccine is low, a VICH Phase 1 assessment is necessary.

7.3

4 months

$1 720

8: Efficacy and safety

A full assessment is needed for the efficacy and target safety of the product.

8.1

6 months

$2 370

9: Non-food trade

Not applicable

10: Special data

An assessment is required as the product contains a GMO.

10.3

7 months

$Nil

11: Finalisation

11.1

3 months

$4 055

12: Limits of use

12

Not applicable

$460

TOTAL

12 months

$19 625

Start an application

To register a new product which contains a new active constituent (Item 2):